Clearance Summary
AMICUS Separator System received FDA 510(k) clearance under submission number K200530, sponsored by Fresenius Kabi AG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2020-09-11.
- Submission: K200530
- Applicant / Sponsor: Fresenius Kabi AG
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.9245
- Decision date: 2020-09-11
Classification & Regulation
This clearance is catalogued under FDA product code GKT and 21 CFR 864.9245, within the Hematology review panel as a Class II device.